HEALTH

FDA issues warning on weight loss products containing undeclared Rx ingredients

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Monday issued an alert to consumers not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent).

Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers’ health at risk.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

These weight loss products, some of which are inappropriately marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores, the FDA noted. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

The following list of brand names are associated with the warning:

Fatloss Slimming, 2 Day Diet, 3x Slimming Power, Japan Lingzhi 24 Hours Diet, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim, 8 Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim Plus, GMP, Imelda Perfect Slim, Lida, DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrim, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

EyeScience releases eye health supplement line at CVS/pharmacy

BY Michael Johnsen

COLUMBUS, Ohio EyeScience Labs on Wednesday launched its advanced ocular nutrition line for age-related macular degeneration and dry eye syndrome at CVS/pharmacy stores nationwide.

EyeScience Macular Health Formula is a complete eye vitamin supplement specifically for AMD. Based on more than two decades of ocular research, EyeScience Macular Health Formula contains 14 clinically proven nutrients to support a healthy retina, the company stated, including omega-3, lutein, zeaxanthin, bilberry, grape seed extract, selenium, L-glutathione and alpha lipoic acid.

EyeScience Dry Eye Formula is a clinically proven supplement that addresses the underlying causes of dry eye syndrome. Unlike conventional eye drops that work from the outside in for immediate and temporary relief, EyeScience Dry Eye Formula targets the root causes of dry eye symptoms internally. The formulation contains a proprietary blend of an omega-3 essential fatty acid, flaxseed oil, lactoferrin, magnesium and vitamins B-6, C and E.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

HHS says ginkgo biloba may not be effective in helping treat dementia

BY Michael Johnsen

WASHINGTON The Department of Health and Human Services on Thursday suggested that the dietary supplement ginkgo biloba is not able to prevent the disease state of dementia, including Alzheimer’s disease, through its HHS HealthBeat, a service launched in 2005 that provides health promotion and disease prevention tips five days a week in audio and text formats.

The Department cited a study of more than 3,000 people over the age of 75 who had normal thinking ability at the start who were either given a ginkgo supplement or a placebo. “The test results showed us that, under these circumstances, ginkgo don’t appear to have any effect of slowing down thinking changes in late life,” stated Steven DeKosky of the University of Virginia, who conducted the study while at the University of Pittsburgh.

The study, published in the Journal of the American Medical Association, was supported by the National Institutes of Health.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?